Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX), which is developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced clinical trial results for a Phase III study of FMX101 for the treatment of moderate-to-severe acne, which met primary end-points.
The company had already conducted two identical Phase III trials for the product in the hope of obtaining rapid marketing approval. One of the trials was successful, but the other failed to obtain the desired results. Foamix accordingly repeated the trial a third time. Positive results of two of its three trials are likely to enable the company to resubmit its product for approval.
Foamix's share price is up 53.2% in premarket trading. The company's current market cap is $241 million.
The latest trial, which was conducted on 1,507 patients, compares the antibiotic in Foamix's foam to the foam without the antibiotic (the product was not tested against other products in the market). A significant improvement was obtained for two targets: the number of acne inflammations was reduced after 12 weeks and the doctor's assessment of the patients improved.
Foamix CEO David Domzalski said, “We are extremely pleased with the topline results of this confirmatory Phase 3 trial. These study results should support a finding that FMX101 appears to be safe and effective in the treatment of moderate-to-severe acne. This is the most significant milestone to date for Foamix and brings us closer to helping patients who struggle with the physical and psycho-social effects of acne. If approved, we believe FMX101 would be the first topical minocycline product available for patients in the US.”
As for the drug's safety, Foamix reported that there were no severe effects, but five patients discontinued the trial because of side effects (three patients in the treatment group and two in the control group treated with the foam without the drug). The orally administered antibiotic in the market also has side effects, but the trial did not compare the products with each other.
If approved, the acne drug will be Foamix's first independent drug in the market. Marketing rights for Foamix's product for treatment of rosacea were previously granted to Bayer, and Foamix posted almost $1 million in revenue from this product in the second quarter of 2018, similar to other quarters. Foamix had $50 million in cash as of the end of the second quarter, following two offerings on Nasdaq.
Published by Globes [online], Israel business news - www.globes-online.com - on September 12, 2018
© Copyright of Globes Publisher Itonut (1983) Ltd. 2018